ANDA 078948

APOTEX INC

FDA Drug Application

Application #078948

Application Sponsors

ANDA 078948

APOTEX INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 150MG BASE

0

IBANDRONATE SODIUM

IBANDRONATE SODIUM

FDA Submissions

	ORIG	1	AP	2012-03-19
LABELING; Labeling	SUPPL	2	AP	2015-07-24	STANDARD
LABELING; Labeling	SUPPL	5	AP	2015-07-24	STANDARD
LABELING; Labeling	SUPPL	6	AP	2015-07-24	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	5	Null	15
SUPPL	6	Null	7

TE Codes

001

Prescription

AB

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78948
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBANDRONATE SODIUM","activeIngredients":"IBANDRONATE SODIUM","strength":"EQ 150MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IBANDRONATE SODIUM","submission":"IBANDRONATE SODIUM","actionType":"EQ 150MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)